Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause

Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause: Blind Sham Controlled Randomized Clinical Trial

Climacteric or Menopausal Transition is defined as the time period where there is a change to non-reproductive reproductive life, with extension of variable length. During this period, and after the establishment of Menopause and non-functioning ovarian, the appearance of various symptoms that express the depletion of ovarian follicles is common; among these symptoms, the most frequently reported by women are vasomotor symptoms or hot flashes. In addition to hormonal therapy, other medications have been employed in an attempt to improve these symptoms; although they present better results than placebo, yet have little clinical impact in reducing vasomotor symptoms. Therefore, this gap allows the evaluation of alternative therapies, such as Transcranial Direct Current Stimulation (tDCS). The rationale for studying the effect of this technique in this context is its possible autonomic modulatory effect. What reinforces the choice of this technique is the fact that it demonstrated efficacy in other pathologies such as depression, pain, Parkinson's disease, among others. Transcranial direct current stimulation (tDCS) is a renewed method of non-invasive brain modulation. It is based on a transcranial application of weak direct currents in a non-invasive, simple and painless manner. Its use in the treatment of vasomotor symptoms has not been studied. The objective of this study is to evaluate the improvement of vasomotor symptoms in postmenopausal women, after application of tDCS, and compare them to a control group. This Randomized Clinical Trial will be held in female postmenopausal patients, followed in the outpatient Menopause Clinic of Obstetrics and Gynecology Service, Hospital de Clinicas de Porto Alegre. From these results, it is expected to present a new therapeutic option in the treatment of vasomotor symptoms.

Study Overview

• Status: Completed
• Conditions: Hot Flashes
• Intervention / Treatment: Procedure: Transcranial Direct Current Stimulation; Procedure: Sham Stimulation

Detailed Description

Primary Outcome: evaluate the effect of tDCS on vasomotor symptoms in postmenopausal women treated at a tertiary hospital in southern Brazil.

Secondary Outcome: compare the effect of tDCS with sham-tDCS in postmenopausal women on vasomotor symptoms, FSH (Follicle Stimulating Hormone) levels, salivary cortisol, BDNF (Brains derived neurotrophic factor)levels,depressive symptoms and quality of life.

Interventions:

• Application of tDCS for a period of 10 consecutive days.
• Transcranial direct current stimulation (tDCS):

Active stimulation: the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: 2 mili Ampere, 20min, 10 days.

Placebo-sham: appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation.

The placebo group do not receive pharmacological treatment or other during the research.

After treatment, patients will be reassessed in a week, a month and three months with new application of questionnaires and sample collection.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

menopause women, any age, with at least, eight hot flashes/day

Exclusion Criteria:

neurological or psychiatric diseases, patients with head injury, women in hormonal replacement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transcranial Direct Current Stimulation; Active Transcranial Direct Current Stimulation: the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: tDCS: 2mili Ampere, 20min, 10 days.	Procedure: Transcranial Direct Current Stimulation; Active Transcranial Direct Current Stimulation : the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: tDCS: 2 mili Ampere, 20min, 10 days.
Placebo Comparator: Sham Stimulation; Sham Stimulation: appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation	Procedure: Sham Stimulation; Sham Stimulation- appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of diary vasomotor symptoms	30 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Maria Celeste Wender, PhD, Hospítal de Clinicas de Professor

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 8, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: 12-0418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No